Policy
No Joke: This Law Is Designed to Protect Vaccine Makers, Not Kids
The time for being fooled is over. The National Childhood Vaccine Injury Act was not a public health victory. It was a legislative coup for vaccine manufacturers, granting them unprecedented legal immunity while leaving the injured with few avenues for justice.
It might be April Fools’ Day, but this law is no joke!
Since 1986, the public has been sold the idea that the National Childhood Vaccine Injury Act (NCVIA) was a necessary safeguard — an essential measure to ensure a stable supply of life-saving vaccines.
But the reality is that it was not a public health victory; it was a legislative coup for vaccine manufacturers, granting them unprecedented legal immunity while leaving the injured with few avenues for justice.
The time for being fooled is over.
A law that protects industry over the injured
The 1986 Act was born out of mounting lawsuits against vaccine manufacturers, particularly over the diphtheria-tetanus-pertussis (DTP) vaccine.
In the early 1980s, parents of vaccine-injured children began successfully suing manufacturers, winning multi-million-dollar settlements.
Pharmaceutical companies, fearing further legal battles, threatened to withdraw from the vaccine market altogether.
But instead of enforcing stricter safety standards or demanding better oversight, Congress capitulated to industry pressure.
With the urging of lobbyists and the backing of public health officials who feared vaccine shortages, lawmakers passed the NCVIA, effectively absolving manufacturers of liability.
The result? A legal fortress that shields vaccine makers, no matter the harm their products may cause.
Under this framework, those injured by vaccines cannot sue manufacturers directly. Instead, they are funnelled into the National Vaccine Injury Compensation Program (VICP) — a bureaucratic labyrinth that rejects nearly half of claims.
For the majority, it’s a dead end. Meanwhile, vaccine makers remain insulated from legal consequences, free to operate without fear of accountability.
Compare this to other industries — if a defective car causes harm, the manufacturer is held responsible. If a medical device malfunctions, the company faces lawsuits.
But if a vaccine results in seizures, brain damage, or even death? The manufacturer walks away unscathed, protected by a government-backed liability shield.
The cost of compensation doesn’t come from Big Pharma’s bottom line — it falls on a government-managed fund, financed by a 75-cent excise tax on every vaccine dose.
While this money doesn’t come directly from general tax revenue, it’s still paid by the public through the purchase of vaccines. In other words, consumers — not manufacturers — bear the financial burden of vaccine injuries.
It’s a system that privatizes profits and socializes risk.
A system designed to avoid scrutiny
By eliminating liability for injury, the 1986 Act removed a crucial incentive for manufacturers to prioritise safety.
Most pharmaceutical products undergo long-term, placebo-controlled clinical trials before approval. Vaccines, however, frequently bypass these standards, often with alarmingly short safety studies, inadequate follow-up periods and non-inert placebos.
In fact, most vaccine trials do not use “true” placebos.
Instead, new vaccines are tested against existing ones or their (reactogenic) adjuvants, making it nearly impossible to detect safety signals.
Consider Sanofi’s Poliovirus Vaccine Inactivated, or IPOL polio vaccine —
The clinical trials relied upon to license this product did not include a control group and only assessed safety for up to three days after injection. That’s not enough time to assess serious adverse events, let alone long-term risks like autoimmune conditions or developmental disorders.
This isn’t science — it’s sleight of hand.
A cash cow with zero financial risk
This lack of rigorous scrutiny pairs with a lucrative business model. Once a vaccine is added to the childhood immunization schedule, it becomes a requirement for millions of children to attend school.
For manufacturers, this is a guaranteed revenue stream — one with no liability attached. No other pharmaceutical product enjoys such extraordinary legal and financial protection.
Critics argue that repealing the 1986 Act would dismantle the VICP, leaving the vaccine-injured without a safety net. But that’s a false choice.
The legal expert I consulted on this matter suggested that a “hybrid” model is possible — one that preserves the existing VICP for those who prefer it while reinstating the right to sue manufacturers directly.
Under this proposed hybrid system, the current excise tax on vaccines could continue to fund the VICP, allowing those seeking full legal recourse to “opt out” and pursue direct legal action against manufacturers.
This would introduce a critical layer of consumer protection, forcing vaccine companies to prioritize safety — not just profits.
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Will RFK Jr. lead the fight to repeal the act?
Few have been as vocal about the dangers of the 1986 Act as Robert F. Kennedy Jr. For years, he has argued that shielding vaccine manufacturers from liability removes any meaningful incentive to ensure product safety.
Now, as head of the U.S. Department of Health and Human Services, he is in a position to push for legislative reform.
Kennedy has long called for vaccines to be held to the same safety standards as other pharmaceutical products.
As Health Secretary, he has the power to work with Congress to revisit the 1986 Act and restore accountability to vaccine manufacturers. If there is any hope of undoing this decades-old mistake, it may rest in his hands.
Restoring accountability and trust
Ultimately, a system that grants vaccine companies extraordinary legal protection while leaving the injured with limited recourse is not just bad policy — it’s a moral failing.
Let’s not be fooled.
The only way to ensure vaccine safety is to hold manufacturers to the same evidentiary standards as every other drug.
That means requiring inert placebo-controlled trials, enforcing long-term safety monitoring, and restoring the fundamental right to legal redress.
We must stop treating vaccines as untouchable, sacrosanct products. They should be subject to the same scrutiny as any other medical therapy — presumed harmful until proven otherwise.
The 1986 Act was a mistake. It must be repealed.
Originally published on Maryanne Demasi’s Substack page.
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